A Study of LY3090106 in Participants With Sjögren's Syndrome (SS)



Status:Completed
Conditions:Rheumatology
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 65
Updated:12/13/2018
Start Date:December 10, 2015
End Date:September 5, 2018

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A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3090106 in Subjects With Sjögren's Syndrome

The main purpose of this study is to learn more about the safety and side effects of the
study drug known as LY3090106 in participants with Sjögren's Syndrome (SS). The study will
also evaluate how much of the study drug gets into the blood stream and how long it takes the
body to remove it.


Inclusion Criteria:

- Have a confirmed diagnosis of SS by the American-European Consensus Group criteria
with active disease (at any level), as per judgment of the investigator (participants
with another concurrent, stable connective tissue disease may be eligible for
inclusion, with written approval from the sponsor).

- Are seropositive for auto-antibodies associated with SS (anti-SSA or anti-SSB) at
screening, or documented within 6 months prior to screening.

Exclusion Criteria:

- Are currently enrolled in a clinical trial involving an investigational product or
off-label use of a drug, are concurrently enrolled in any other type of medical
research judged not to be scientifically or medically compatible with this study, or
have received:

- Any nonbiologic investigational product within 30 days or 5 half-lives (whichever
is longer) of study baseline,

- Any biologic investigational product within 3 months or 5 half-lives (whichever
is longer) of study baseline, or any leukocyte depleting agent within 12 months
of baseline,

- Have synthetic disease-modifying anti-rheumatic drug (DMARD) or immunosuppressive use
as follows:

- Any treatment with tofacitinib within 28 days prior to baseline or planned
treatment with tofacitinib during the study,

- Unstable prescribed dose of other synthetic DMARDs (eg, hydroxychloroquine,
methotrexate, leflunomide, sulfasalazine, or gold salts) within 28 days prior to
baseline or if the dose of drug is planned to be increased during the study.
(Stable prescriptions are allowed.)

- Cytotoxic or immunosuppressive drugs including but not limited to
cyclophosphamide, mycophenolic acid, azathioprine, cyclosporine, sirolimus, or
tacrolimus within 28 days prior to screening or planned treatment during the
study.

- Have had treatment with biologic DMARDs as follows:

- Etanercept, adalimumab, or anakinra <4 weeks before baseline or planned treatment
during the study.

- Infliximab, certolizumab pegol, golimumab, abatacept, or tocilizumab <8 weeks
before baseline or planned treatment during the study.

- Rituximab, belimumab or other leukocyte depleting agent <12 months before
baseline or planned treatment during the study. Note: other biologic agents may
be allowed after written approval from the sponsor.

- Have a prescribed dose >10 milligrams (mg)/day of oral prednisone (or equivalent)
within 28 days before baseline, or plan to increase >10 mg/day during the study.
(Stable prescriptions ≤10 mg/day are allowed.) Treatment with inhaled or parenteral
corticosteroids within 28 days prior to baseline is prohibited. A single
intra-articular corticosteroid injection is permitted within 28 days prior to baseline
if no more than 40 mg triamcinolone (or equivalent) is administered. The treated joint
should be excluded from any joint-specific evaluations during the study.

- Have an unstable prescribed dose of a cholinergic stimulant (eg, pilocarpine,
cevimeline) within 28 days prior to baseline. (Stable prescriptions are allowed.)

- Have an unstable prescribed dose of cyclosporine eye drops within 28 days prior to
baseline. (Stable prescriptions are allowed.)
We found this trial at
5
sites
Albuquerque, New Mexico 87106
Principal Investigator: Lance Rudolph
Phone: 505-855-5505
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4940 Eastern Ave
Baltimore, Maryland 21224
(410) 550-0100
Principal Investigator: T Grader-Beck
Phone: 410-550-2039
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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Concord, North Carolina 28025
Principal Investigator: G Lam
Phone: 704-403-1308
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Concord, NC
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Duncansville, Pennsylvania 16635
Principal Investigator: A J Kivitz
Phone: 814-639-0300
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Sofia,
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